Constricting Pressure Valve Apparatus and Methods Thereof

ABSTRACT

A valve apparatus and methods associated thereof are provided. The valve apparatus includes a valve housing structure. A first valve portion is connected to the valve housing structure, wherein the first valve portion has a sealing edge. A second valve portion is positioned at least partially within the valve housing structure. A constrictable membrane has a pressurizable interior compartment, wherein the constrictable membrane supported by the second valve portion and positioned proximate to the first valve portion, wherein at least a portion of the constrictable membrane is movable to engageable with the sealing edge of the first valve portion.

FIELD OF THE DISCLOSURE

The present disclosure is generally related to valves and moreparticularly is related to a constricting pressure valve apparatus foruse with a medical sterilization container.

BACKGROUND OF THE DISCLOSURE

Articles such as medical instruments and the like are usually sterilizedin an autoclave in which the articles are exposed to high-pressuresaturated steam for a relatively brief interval. Unless the articles areto be used immediately and in close proximity to the autoclave, it isdesirable to sterilize the articles while they are inside a valvedcontainer as described, for example, in U.S. Pat. No. 4,748,003. Duringthe sterilization process, the valves open under the influence of highpressure steam in the autoclave exposing the contents of the containerto the hot steam. At the end of the sterilization cycle, when thepressure in the autoclave outside the container is returned to normal,i.e. atmospheric pressure, the valves close so that when the containeris removed from the autoclave, the now sterilized articles aremaintained in a completely sealed sterile environment until they areneeded.

The sterilization container described in the above patent haspressure-actuated valves in the top and bottom walls of thesterilization container. Each valve has a large valve opening and aclosure therefor, the latter being supported by a bellows capsulemounted inside the container. A return spring mechanism normallymaintains the valve closure in its closed position. However, when thepressure outside the container exceeds that within the container by afew pounds per square inch, the force on the valve closure exceeds thatexerted by the return spring with the result that the valve closureopens sufficiently to allow high-pressure steam to enter the container.That steam collapses the bellows, which thereupon moves the valveclosure to its fully open position. Both valves being open,high-pressure steam can sweep through the container and sterilize thearticles therein. When the pressure inside the autoclave returns tonormal after completion of the sterilization cycle, the return springmoves the valve closure of each valve to its closed position therebysealing the container. As also described in that patent, pressureequalization occurs through a special filter member mounted in thecontainer wall so that a sterile environment at ambient pressure ismaintained in the container until the container is opened to remove thearticles therefrom.

While the valve described in the above patent operates satisfactorily,it does have certain to drawbacks. First and foremost, the bellowscapsule has a relatively small diameter in relation to the valve openingand a large length-to-diameter ratio, e.g. 1.3 in./1 in.=1.3. This meansthat when the valve member starts to open in response to a givenpressure differential outside and inside the container and the bellowsis collapsed lengthwise, there is a relatively large reduction in thevolume of the bellows, i.e. in excess of 20%, and a correspondinglylarge increase in gas pressure inside the bellows which resists furtheropening of the valve member. To avoid this problem, the bellows capsulein the prior value has to be evacuated. This necessitates the use of anelaborate return spring mechanism in order to overcome the increasedback pressure and close the valve. Also, the requirement for a bellowsthat must be evacuated makes the valve somewhat more difficult andexpensive to manufacture. In addition, sometimes a small leak maydevelop in the bellows so that air enters the bellows. Resultantly,during the next sterilization cycle, when the valve member begins toopen, that air will be compressed, effectively increasing the springconstant of the bellows so that the valve member does not open as muchfor a given pressure differential outside and inside the container.

Thus, a heretofore unaddressed need exists in the industry to addressthe aforementioned deficiencies and inadequacies.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure provide a valve apparatus. Brieflydescribed, in architecture, one embodiment of the apparatus, amongothers, can be implemented as follows. The valve apparatus includes avalve housing structure. A first valve portion is connected to the valvehousing structure, wherein the first valve portion has a sealing edge. Asecond valve portion is positioned at least partially within the valvehousing structure. A constrictable membrane has a pressurizable interiorcompartment, wherein the constrictable membrane supported by the secondvalve portion and positioned proximate to the first valve portion,wherein at least a portion of the constrictable membrane is movable toengageable with the sealing edge of the first valve portion.

The present disclosure can also be viewed as providing systems forsterilizing medical instruments. Briefly described, in architecture, oneembodiment of the system, among others, can be implemented as follows.The system for sterilizing medical instruments includes a sterilizationcontainer having a plurality of walls, a base, and a top, wherein atleast a portion of the plurality of walls, the base, and the topsubstantially enclose the sterilization container. A valve housingstructure is positioned within at least one of the plurality of walls,the base, and the top. A first valve portion is connected to the valvehousing structure, wherein the first valve portion has a sealing edge. Asecond valve portion is positioned at least partially within the valvehousing structure. A constrictable membrane has a pressurizable interiorcompartment, wherein the constrictable membrane supported by the secondvalve portion and positioned proximate to the first valve portion,wherein at least a portion of the constrictable membrane is movable toengageable with the sealing edge of the first valve portion.

The present disclosure can also be viewed as providing methods ofsterilizing a medical instrument. In this regard, one embodiment of sucha method, among others, can be broadly summarized by the followingsteps: placing a sterilization container having the medical instrumentpositioned therein within a sterilization environment; heating thesterilization environment, thereby opening a constricting valvepositioned within the sterilization container; transferring a sterilantthrough the constricting valve to sterilize the medical instrumentpositioned within the sterilization container; after the medicalinstrument is sterilized, decreasing a temperature of the sterilizationenvironment to close the constricting valve, whereby the closedconstricting valve seals the sterilization container and prevents abiological contaminant from accessing the medical instrument therein;and removing the sterilization container from the sterilizationenvironment.

Other systems, methods, features, and advantages of the presentdisclosure will be or become apparent to one with skill in the art uponexamination of the following drawings and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description, be within the scope ofthe present disclosure, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the disclosure can be better understood with referenceto the following drawings. The components in the drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present disclosure. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

FIG. 1 is a cross-sectional illustration of a valve apparatus, inaccordance with a first exemplary embodiment of the present disclosure.

FIG. 2 is a cross-sectional illustration of a valve apparatus of FIG. 1in a non-engaged position, in accordance with the first exemplaryembodiment of the present disclosure.

FIG. 3 is a cross-sectional illustration of a valve apparatus within asterilization container, in accordance with the first exemplaryembodiment of the present disclosure.

FIG. 4 is a cross-sectional illustration of a valve apparatus, inaccordance with a second exemplary embodiment of the present disclosure.

FIG. 5 is a cross-sectional illustration of a valve apparatus of FIG. 4in a non-engaged position, in accordance with the second exemplaryembodiment of the present disclosure.

FIG. 6 is a flowchart illustrating a method of sterilizing a medicalinstrument, in accordance with the first exemplary embodiment of thepresent disclosure.

DETAILED DESCRIPTION

FIG. 1 is a cross-sectional illustration of a valve apparatus 10, inaccordance with a first exemplary embodiment of the present disclosure.The valve apparatus 10, which may be referred to herein as ‘apparatus10’ includes a valve housing structure 40. A first valve portion 30 isconnected to the valve housing structure 40, wherein the first valveportion 30 has a sealing edge 32. A second valve portion 20 ispositioned at least partially within the valve housing structure 40. Aconstrictable membrane 50 has a pressurizable interior compartment 29,where the constrictable membrane 50 is supported by the second valveportion 20 and positioned proximate to the first valve portion 30. Atleast a portion of the constrictable membrane 50 is movable toengageable with the sealing edge 32 of the first valve portion 30.

The valve apparatus 10 may include any type of valve used with any typeof structure. Preferably, the valve apparatus 10 is used with a medicalinstrument sterilization container used to sterilize medical instrumentsbefore and after medical procedures. The valve apparatus 10, however,can be used with other structures conventionally used with asterilization process, and/or capable of enduring a sterilizationprocess, or structures that are not used for sterilization processes.

The valve housing structure 40 may include any device, structure,portion of a structure or combination thereof that supports or isconnected to one of the first and second valve portions 30, 20. Forexample, the valve housing structure 40 may be integral with the firstvalve portion 30 and may be affixed, by any means, such as bonding,gluing and/or ultrasonic welding to the sterilization container.Alternatively, the valve housing structure 40 may be affixed with anytype of fastener to the second valve portion 20. In FIG. 1, the secondvalve portion 20 is affixed to the valve housing structure 40 with athreaded fastener 22. As can be seen, any number or type of valvehousing structures 40 may be used in any combination to secure, positionor support the valve apparatus 10 to a sterilization container.

The first valve portion 30 and the second valve portion 20 may includeany type of valve portions that are positioned proximate to each other.As is illustrated in FIG. 1, the first valve portion 30 is affixed tothe valve housing structure 40, which may be in communication with asterilization container. The first valve portion 30 may be permanentlyor removably affixed or attached to the valve housing structure 40 withany device or process. For example, as is shown in FIG. 1, the firstvalve portion 30 is integrally bonded with the valve housing structure40.

The first and second valve portions 30, 20 may be characterized as anytype of structures within a valve that are positioned proximate to oneanother. The identifications of a ‘first’ and/or ‘second’ portion areincluded to convey the details of the present disclosure, and should notbe read to limit the scope valve apparatus 10. The first and secondvalve portions 30, 20 may include a variety of designs and structures,all of which are considered within the scope of the present disclosure.For example, in FIG. 1, the first valve portion 30 is positioned aboutthe circumference of the second valve portion 20, thus positioning thesealing edge 32 circumferentially about the constrictable membrane 50.The second valve portion 20 includes an interior portion having apressurizable interior compartment 29 defined by any part or parts ofthe second valve portion 20 and/or the constrictable membrane 50. Thepressurizable interior compartment 29 may be capable of holding apressurized atmosphere, such as an atmospheric pressure of approximately14.7 pounds per square inch (psi). The pressurized interior compartment29 may be formed from any combination of the structure of the secondvalve portion 20 and the constrictable membrane 50.

The constrictable membrane 50 may include any type of membrane, flexiblematerial, substantially flexible material and/or any other device ormaterial capable of constricting. For example, the constrictablemembrane 50 may include a rubber material and/or a silicone materialthat is able to flex, bend and move. The constrictable membrane 50 maybe attached to at least a portion of the second valve portion 20,wherein the constrictable membrane 50 is positioned on an exteriorsurface of the second valve portion 20, such as by stretching theconstrictable membrane 50 over the exterior surface. In accordance withthis disclosure, a constrictable membrane 50 attached to the secondvalve portion 20 may include a constrictable membrane 50 that isintegral with, bonded to, coupled to, fastened to and/or engaged withany part of the first valve portion. In FIG. 1, the constrictablemembrane 50 is illustrated as covering an upper valve part 24, an opensidewall 26 and a portion of the bottom valve part 28 of the secondvalve portion 20. The upper and lower valve parts 24, 28 may be affixedto the valve housing with the threaded fastener 22, or anotherstructure. The constrictable membrane 50 may be affixed to the secondvalve portion 20 by any type of attachment device 52 or attachmentmethod. This may include a device and/or any bonding or adhesive processthat retains the constrictable membrane 50 securely.

As is illustrated in FIG. 1, the constrictable membrane 50 may bepositioned over an open sidewall 26 of the second valve portion 20. Theopen sidewall 26 may be characterized as a gap between the upper andbottom valve parts 24, 28 of the second valve portion 20. In thisposition, the constrictable membrane 50 may contact and engage a sealingedge 32 of the first valve portion 30, which may create a seal or sealedjunction between the constrictable membrane 50 and the first valveportion 30. The sealing edge 32 of the first valve portion 30 may bepositioned between the upper and bottom valve parts 24, 28 of the secondvalve portion 20, to position the sealing edge 32 appropriately forcontact with the constrictable membrane 50. This seal between thesealing edge 32 and the constrictable membrane 50 may be capable ofpreventing the flow of a sterilization material and/or gas fromtraversing through the valve apparatus 10. Accordingly, when theconstrictable membrane 50 is engaged with the first valve portion 30,any interior portion (not shown) of the sterilization container may besealed off from substances or an atmosphere exterior to thesterilization container.

FIG. 2 is a cross-sectional illustration of a valve apparatus 10 of FIG.1 in a non-engaged position, in accordance with a first exemplaryembodiment of the present disclosure. In other words, FIG. 2 illustratesthe valve apparatus 10 in the open position, whereas FIG. 1 illustratesthe valve apparatus 10 in the closed position, as discussed above. Ascan be seen in FIG. 2, the constrictable membrane 50 may be in thenon-engaged or non-contacting position when it is positioned to create avoid 54 between the constrictable membrane 50 and the first valveportion 30 to allow the flow of gasses and/or sterilant through thevalve apparatus 10. The valve apparatus 10 may function by allowing thetransmission of a sterilization material, a gas, a liquid and/or apressurized atmosphere from one side of the valve apparatus 10 to theother side. The void 54 may permit the sterilization material, gas,liquid and/or pressurized atmosphere to traverse through the valveapparatus 10. Thus, the first and second valve portions 30, 20 mayremain in substantially constant relative positions to one another whilethe constrictable membrane 50 is flexed between positions.

Movement between the closed position shown in FIG. 1 and the openposition shown in FIG. 2 may occur through the application of pressureto and/or within the sterilization container. Pressure may be applied inany pressurized environment, such as an autoclave chamber used to createhigh pressure and high heat for a sterilization process, relative to anambient heat and pressure external to the autoclave chamber. Forexample, the sterilization container with valve apparatus 10 may beplaced within an autoclave chamber. When the pressure within theautoclave chamber is substantially equal to that outside the autoclavechamber, the constrictable membrane 50 may remain in the closed/engagedposition. When the pressure in the autoclave chamber increases, such asfrom the application of heat in a sterilization process, theconstrictable membrane 50 may be forced to move from the closed/engagedposition to the open/non-engaged position. This movement of theconstrictable membrane 50 is due to the pressure within the interiorportion of the second valve portion 20 remaining at an atmosphericpressure of approximately 14.7 psi, while the pressure within theautoclave chamber increases above the atmospheric pressure. For example,the pressure within the autoclave chamber may increase up toapproximately 42 psi. Thus, as the pressure within the autoclave chamberis adjusted, the position of the constrictable membrane 50 between afully closed, fully engaged position with the first valve portion 30 andan open, non-engaged position with the first valve portion 30 may beachieved.

FIG. 3 is a cross-sectional illustration of a valve apparatus 10 withina sterilization container 12, in accordance with the first exemplaryembodiment of the present disclosure. As is shown in FIG. 3, the valveapparatus 10 is positioned within a wall of the sterilization container12. The valve housing structure 40 of the valve apparatus 10 may bepositioned within one or more of the top 13, the base 15, and/or one ofthe sidewall 14 of a sterilization container 12. Preferably, the valveapparatus 10 will be positioned within the top 13 of the sterilizationcontainer 12 to allow for easy access to the valve apparatus 10 by amedical practitioner and to provide unobstructed access of a sterilantto the valve apparatus 10. The valve apparatus 10 may be positionedbetween an exterior atmosphere of the sterilization container 12 and aninterior area 16 of the sterilization container 12 where one or moremedical instruments 17 are housed. As was discussed previously, thesterilization container 12 may be used to sterilize a variety of medicaltools and devices to make them safe for use in a medical procedure. Thesterilization container 12 may include any variety of containers, suchas those that are placed within a sterilization machine or autoclave,and/or containers that include internal sterilization mechanisms.

FIG. 4 is a cross-sectional illustration of a valve apparatus, inaccordance with a second exemplary embodiment of the present disclosure.The valve apparatus 110, which may be referred to herein as ‘apparatus110’ may include any of the features, structures, or configurationsdisclosed with respect to the first exemplary embodiment. The valveapparatus 110 includes a valve housing structure 140. A first valveportion 130 is connected to the valve housing structure 140, wherein thefirst valve portion 130 has a sealing edge 132. A second valve portion120 is positioned at least partially within the valve housing structure140. A constrictable membrane 150 has a pressurizable interiorcompartment 129, where the constrictable membrane 150 is supported bythe second valve portion 120 and positioned proximate to the first valveportion 130. At least a portion of the constrictable membrane 150 ismovable to engageable with the sealing edge 132 of the first valveportion 130.

The valve apparatus 110 may function substantially similar to the valveapparatus 10 of the first exemplary embodiment, in that theconstrictable membrane 150 may move between at least a first positionwhere the constrictable membrane 150 engages the sealing edge 132 of thefirst valve portion 130 to create a seal, and a second position wherethe constrictable membrane 150 does not contact the sealing edge 132 ofthe first valve portion 130. However, the valve apparatus 110 differs inthat the constrictable membrane 150 may be a sphere or spheroid shapeand not stretched over parts of the second valve apparatus 120. Theconstrictable membrane 150 as a sphere or spheroid shape may decreaseand increase in size with the varying pressure and temperature inside anautoclave, and in ambient atmospheric temperatures and pressures. As isshown in FIG. 4, the constrictable membrane 150 is in the closedposition such that it contacts the sealing edge 132 of the first valveportion 130. In this position, the constrictable membrane 150 preventsthe flow of fluid, gasses, or other materials through the valveapparatus 110.

FIG. 5 is a cross-sectional illustration of a valve apparatus 110 ofFIG. 4 in a non-engaged position, in accordance with the secondexemplary embodiment of the present disclosure. Compared to FIG. 1,which illustrates the valve apparatus 110 in the closed position, FIG. 5illustrates the valve apparatus 110 in the open position. With referenceto FIGS. 4 and 5, constrictable membrane 150 may be in the non-engagedor non-contacting position when it is positioned to create a void 154between the constrictable membrane 150 and the first valve portion 130to allow the flow of gasses and/or sterilant through the valve apparatus110. The valve apparatus 110 may function by allowing the transmissionof a sterilization material, a gas, a liquid and/or a pressurizedatmosphere from one side of the valve apparatus 110 to the other side.The void 154 may permit the sterilization material, gas, liquid and/orpressurized atmosphere to traverse through the valve apparatus 110.Thus, the first and second valve portions 130, 120 may remain insubstantially constant relative positions to one another while theconstrictable membrane 150 is flexed between positions.

Movement between the closed position shown in FIG. 4 and the openposition shown in FIG. 5 may occur through the application of pressureto and/or within the sterilization container. Pressure may be applied inany pressurized environment, such as an autoclave chamber used to createpressure and heat for a sterilization process. For example, thesterilization container with valve apparatus 110 may be placed within anautoclave chamber. When the pressure within the autoclave chamber issubstantially equal to that outside the autoclave chamber, theconstrictable membrane 150 may remain in the closed/engaged position.When the pressure in the autoclave chamber increases, such as from theapplication of heat in a sterilization process, the constrictablemembrane 150 may be forced to move from the closed/engaged position tothe open/non-engaged position. This movement of the constrictablemembrane 150 is due to the pressure within the interior portion of thesecond valve portion 120 remaining at an atmospheric pressure ofapproximately 14.7 psi, while the pressure within the autoclave chamberincreases above the atmospheric pressure. For example, the pressurewithin the autoclave chamber may increase up to approximately 42 psi.Thus, as the pressure within the autoclave chamber is adjusted, theposition of the constrictable membrane 150 between a fully closed, fullyengaged position with the first valve portion 130 and an open,non-engaged position with the first valve portion 130 may be achieved.

FIG. 6 is a flowchart 200 illustrating a method of sterilizing a medicalinstrument in accordance with the first exemplary embodiment of thedisclosure. It should be noted that any process descriptions or blocksin flow charts should be understood as representing modules, segments,portions of code, or steps that include one or more instructions forimplementing specific logical functions in the process, and alternateimplementations are included within the scope of the present disclosurein which functions may be executed out of order from that shown ordiscussed, including substantially concurrently or in reverse order,depending on the functionality involved, as would be understood by thosereasonably skilled in the art of the present disclosure.

As is shown by block 202, a sterilization container having the medicalinstrument positioned therein is placed within a sterilizationenvironment. The sterilization environment is heated, thereby opening aconstricting valve positioned within the sterilization container (block204). A sterilant is transferred through the constricting valve tosterilize the medical instrument positioned within the sterilizationcontainer (block 206). After the medical instrument is sterilized, atemperature of the sterilization environment is decreased to close theconstricting valve, whereby the closed constricting valve seals thesterilization container and prevents a biological contaminant fromaccessing the medical instrument therein (block 208). The sterilizationcontainer is removed from the sterilization environment (block 210).

The method may include any additional number of steps, variations, orfunctions, including any steps, variations, or functions disclosed withrespect to FIGS. 1-5 above. For example, heating the sterilizationcontainer may disengage a constrictable membrane having a pressurizableinterior compartment from a sealing edge of a first valve portionaffixed to a valve housing structure. Similarly, cooling thesterilization container may engage the constrictable membrane having thepressurizable interior compartment from the sealing edge of the firstvalve portion affixed to the valve housing structure. The constrictablemembrane having the pressurizable interior compartment may remain closedto seal the sterilization container under ambient atmospheric pressures.The sterile conditions within the sterilization container may bemaintained for any period of time after it is removed from thesterilization environment.

It should be emphasized that the above-described embodiments of thepresent disclosure, particularly, any “preferred” embodiments, aremerely possible examples of implementations, merely set forth for aclear understanding of the principles of the disclosure. Many variationsand modifications, including variations of devices, structures,processes and methods, may be made to the above-described embodiment(s)of the disclosure without departing substantially from the spirit andprinciples of the disclosure. All such modifications and variations areintended to be included herein within the scope of this disclosure andthe present disclosure and protected by the following claims.

What is claimed is:
 1. A valve apparatus comprising: a valve housingstructure; a first valve portion connected to the valve housingstructure, wherein the first valve portion has a sealing edge; a secondvalve portion positioned at least partially within the valve housingstructure; and a constrictable membrane having a pressurizable interiorcompartment, the constrictable membrane supported by the second valveportion and positioned proximate to the first valve portion, wherein atleast a portion of the constrictable membrane is movable to engageablewith the sealing edge of the first valve portion.
 2. The valve apparatusof claim 1, wherein the valve housing structure is positioned within atleast one of a top, a base, and a sidewall of a medical instrumentsterilization container.
 3. The valve apparatus of claim 1, wherein atleast a portion of the constrictable membrane is movable between atleast a first position where the constrictable membrane engages thesealing edge of the first valve portion to create a seal, and a secondposition where the constrictable membrane does not contact the sealingedge of the first valve portion.
 4. The valve apparatus of claim 3,wherein when the constrictable membrane is in the first position,movement of a gaseous material through the valve housing structure isrestricted.
 5. The valve apparatus of claim 3, wherein the secondposition of the constrictable membrane corresponds to at least one of ahigh heat and a high pressure condition within a sterilizationenvironment, relative to an ambient heat and an ambient pressure.
 6. Thevalve apparatus of claim 1, wherein the constrictable membrane isstretched over an exterior surface of the second valve portion.
 7. Thevalve apparatus of claim 1, wherein the second valve portion ispositioned within the valve housing structure with a threaded fastener.8. The valve apparatus of claim 1, wherein the second valve portionfurther comprise at least an upper valve part and a lower valve part,wherein the constrictable membrane is affixed between the upper andlower valve parts.
 9. The valve apparatus of claim 8, wherein the uppervalve part and the lower valve part are affixed to the valve housingwith a threaded fastener.
 10. The valve apparatus of claim 8, furthercomprising a gap between the upper and lower valve parts, wherein theconstrictable membrane is positioned across the gap.
 11. The valveapparatus of claim 10, wherein the sealing edge of the first valveportion is positioned within the gap formed between the upper and lowervalve parts, wherein the constrictable membrane is movable between atleast a first position where the constrictable membrane engages thesealing edge of the first valve portion to create a seal, and a secondposition where the constrictable membrane does not contact the sealingedge of the first valve portion.
 12. The valve apparatus of claim 1,wherein the sealing edge of the first valve portion is circumferentiallypositioned about the constrictable membrane.
 13. The valve apparatus ofclaim 1, wherein the constrictable membrane is one of a sphere and aspheroid.
 14. A system for sterilizing medical instruments comprising: asterilization container having a plurality of walls, a base, and a top,wherein at least a portion of the plurality of walls, the base, and thetop substantially enclose an interior area of the sterilizationcontainer; a valve housing structure positioned within at least one ofthe plurality of walls, the base, and the top; a first valve portionconnected to the valve housing structure, wherein the first valveportion has a sealing edge; a second valve portion positioned at leastpartially within the valve housing structure; and a constrictablemembrane having a pressurizable interior compartment, the constrictablemembrane supported by the second valve portion and positioned proximateto the first valve portion, wherein at least a portion of theconstrictable membrane is movable to engageable with the sealing edge ofthe first valve portion.
 15. The system for sterilizing medicalinstruments of claim 14, wherein at least a portion of the constrictablemembrane is movable between at least a first position where theconstrictable membrane engages the sealing edge of the first valveportion to seal an interior area of the sterilization container from anexterior atmosphere, and a second position where the constrictablemembrane does not contact the sealing edge of the first valve portion toprovide a pathway through the valve housing structure between theinterior area of the sterilization container and the exterioratmosphere.
 16. A method of sterilizing a medical instrument, the methodcomprising the steps of: placing a sterilization container having themedical instrument positioned therein within a sterilizationenvironment; heating the sterilization environment, thereby opening aconstricting valve positioned within the sterilization container;transferring a sterilant through the constricting valve to sterilize themedical instrument positioned within the sterilization container; afterthe medical instrument is sterilized, decreasing a temperature of thesterilization environment to close the constricting valve, whereby theclosed constricting valve seals the sterilization container and preventsa biological contaminant from accessing the medical instrument therein;and removing the sterilization container from the sterilizationenvironment.
 17. The method of claim 16, wherein the step of heating thesterilization environment, to open the constricting valve positionwithin the sterilization container further comprises disengaging aconstrictable membrane having a pressurizable interior compartment froma sealing edge of a first valve portion affixed to a valve housingstructure.
 18. The method of claim 16, wherein the step of decreasing atemperature of the sterilization environment to close the constrictingvalve to close the constricting valve and seal the sterilizationcontainer further comprises engaging a constrictable membrane having apressurizable interior compartment from a sealing edge of a first valveportion affixed to a valve housing structure.
 19. The method of claim18, wherein the constrictable membrane having the pressurizable interiorcompartment remains closed to seal the sterilization container underambient atmospheric pressures.
 20. The method of claim 16, furthercomprising the step of maintaining sterile conditions within thesterilization container after it is removed from the sterilizationenvironment.